FDA.reportPublic FDA data

Dermal Cooling System

Primary DI
00850019947991
Brand
Dermal Cooling System
Company
R2 DERMATOLOGY INC.
Model
M1-TIP1-20
Catalog number
M1-TIP1-20
Device description
Dermal Cooling System smooth tip
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILOPack, hot or cold, water circulating
QPZContact cooling for skin lesion pain relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2
QPZContact Cooling For Skin Lesion Pain ReliefGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213294000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213294000Dermal Cooling SystemR2 Technologies, Inc.2022-11-10QPZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850019947564PrimaryGS10
00850019947861PrimaryGS10
00850019947991Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850019947564008500199475648500199475640850019947564
00850019947861008500199478618500199478610850019947861
00850019947991008500199479918500199479910850019947991

GMDN Terms#

Term, Definition table
TermDefinition
General cryosurgical system, thermo-electric coolerAn assembly of electrically-powered devices designed to ablate benign lesions of the skin through cooling (cryosurgery) and may in addition be intended for temporary reduction of pain, swelling, inflammation, and/or hematoma associated with minor surgical procedures. It includes a control unit, thermoelectric cooling unit and a noninvasive handpiece typically mounted on a mobile stand/trolley; it is not intended to use liquid refrigerant (cryogen).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(925)378-4400info@r2technologies.com

Regulatory Flags#

DUNS number
080023734
Device count
20
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850019947632Dermal Cooling SystemM1-TIP3-20M1-TIP3-202023-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00311917069159WalgreensWALGREEN CO.ILO2025-08-22
00810113577517ViveVIVE HEALTH LLCILO2024-08-20
00810041987617ViveVIVE HEALTH LLCILO2024-07-17
10850007350090Mul-T-PadC2DX, INC.ILO2024-01-09
10850007350106Mul-T-PadC2DX, INC.ILO2024-01-09
10850007350120Mul-T-PadC2DX, INC.ILO2024-01-09
20850007350073Mul-T-PadC2DX, INC.ILO2024-01-09
20850007350110T/PadC2DX, INC.ILO2024-01-09
00810041981523ViveVIVE HEALTH LLCILO2023-08-07
08809802644038CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-15
08809802644045CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-15
08809802644021CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-12
00812120001412Game Ready Articulated Knee Heat Exchanger, RentalAvanos Medical, Inc.ILO2023-04-05
00812120001429Game Ready Right Shoulder Heat Exchanger, RentalAvanos Medical, Inc.ILO2023-04-05
00812120001436Game Ready Left Shoulder Heat Exchanger, RentalAvanos Medical, Inc.ILO2023-04-05
00812120001535Game Ready Straigh Knee Wrap - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001542Game Ready Articulated Knee Wrap - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001566Game Ready Ankle Wrap - Large - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001580Game Ready Shoulder Wrap - Medium - Right - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001597Game Ready Shoulder Wrap - Medium - Left - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001603Game Ready Shoulder Wrap - Large - Right - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001634Game Ready C-T Spine Wrap - Large - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001658Game Ready Hip/Groin Wrap - Left - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001672Game Ready Flexed Elbow Wrap - DemoAvanos Medical, Inc.ILO2023-04-05
00812120002662Game Ready Med4 Elite Drain HoseAvanos Medical, Inc.ILO2023-04-05
08809802643260CTC-7DAESUNG MAREF CO.,LTD.ILO2022-05-09
00810041988126ViveVIVE HEALTH LLCILO2021-11-30